Ethical Issues Related to Testing Anthrax Vaccine on Children

April 02, 2013

Story at-a-glance

The US government has proposed the need for a trial in children of anthrax vaccine, framing it as a necessary step in protecting them from the effects of a potential future bioterrorism attack using weaponized anthrax

The Alliance for Human Research Protection (AHRP) is in strong opposition to the trial and has submitted an exposé to Amy Gutman, PhD, Chair of the Presidential Commission for the Study of Bioethical Issues

Experimenting on the most vulnerable members of our society with a dangerous vaccine without the promise of any benefit to them is heartless, unethical and unnecessary, not to mention violates a number of federal regulations protecting children

The entire premise that we are at high risk for a bioterrorist attack is erroneous, and the idea that a vaccine is needed is ludicrous when antibiotics have proven 100 percent effective for anthrax exposure

The AHRP suggests the government’s motivation for this vaccine trial may be a backdoor effort to capitalize on the public’s post-9/11 fear with the goal of expanding civilian vaccinations and increasing vaccine profits by any means possible, while turning a blind eye to the well-known risks

By Dr. Mercola

The US government has proposed a children's trial of anthrax vaccine arguing that it is a necessary step in protecting them from the effects of a potential future bioterrorism attack using weaponized anthrax.

The Alliance for Human Research Protection (AHRP) is in strong opposition to this idea, and rightly so. Experimenting on the most vulnerable members of our society with a dangerous vaccine, without the promise of any benefit, is both heartless and unnecessary — not to mention highly unethical.

The fact that anthrax is a dangerous bacterium deserving our concern if it is weaponized is not the issue. Unlike most other bacteria, anthrax forms very potent spores that can remain alive under harsh conditions for 100 years or longer.

The rugged survivability of the anthrax spore is what could make it a powerful biological weapon. For example, it can easily survive being dropped from an airplane or exploded in a bomb.

The issue is that your risk for anthrax exposure has been vastly blown out of proportion. History tells us that exposure to anthrax is extremely rare, and bioterrorism experts say the likelihood of it ever being used as an agent of attack on a mass scale is negligible.

Fortunately, the idea of trying out the anthrax vaccine on children has met with fierce opposition. In fact, even Paul Offit, a pediatric vaccine developer and long-time vaccine advocate, advised against such a trial.1

On February 18, 2013, AHRP sent a detailed exposé to Amy Gutman, PhD, Chair of the Presidential Commission for the Study of Bioethical Issues, which is the committee assigned the task (by DHHS Secretary Sebelius) of evaluating the ethical problems with the proposed vaccine trial.

The Commission met four times over the past year regarding this issue, having completed their deliberations in January 2013. You can read the complete transcript of their final discussion here.2

This powerful exposé, authored by Vera Sharav and Dr. Meryl Nass of AHRP, is a convincing argument that exposes the many flaws in logic, misleading propaganda, and ethics violations of this proposed vaccine trial. What follows is a synopsis of the concerns covered in their exposé.

Anthrax as a Bioterrorism Agent is Extremely Unlikely

In modern times, no foreign enemy has used biological weapons against Americans, neither military nor civilian.

The only possible exception was the anthrax-laced mail attack in October 2001. The federal government has maintained that a scientist in charge of anthrax vaccine testing at a US military lab, who is now dead, was to blame for the anthrax letter attacks although others have suggested the mystery is not solved and the investigation should continue.3 Since 2001, there have been no credible reports about an anthrax bioterrorism threat to the U.S. civilian population.

How can they declare an emergency when there is no evidence for one?

In the anthrax-laced mail attack of 2001, thousands of people were exposed to anthrax spores. Antibiotics were successful in preventing illness in 100 percent of those treated after exposure. Five people died, but their cases were recognized very late. There was no additional benefit from using anthrax vaccine over antibiotics alone and the vaccine was accepted by less than two percent of those who received antibiotics.

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Why Do We Need the Anthrax Vaccine when Antibiotics have Proven 100 Percent Effective?

The anthrax vaccine, BioThrax,4 manufactured by Emergent BioSolutions, has never been proven effective in humans against inhaled anthrax and is not licensed for post-exposure use, even in adults. Two papers published in 2012 by top anthrax scientists (Ingram and Baillie, and Bellanti, et al) confirm this point. Because there is no animal model for anthrax vaccine response that translates to humans, there is no human efficacy data for adults or children; therefore, it's impossible to derive effectiveness data for children from any anthrax trial that DHHS may propose.

That said, why would a vaccine be needed when there is already a treatment proven to be 100 percent effective? As stated above, prompt treatment with antibiotics after anthrax exposure was 100 percent effective for all 30,000 people exposed in 2001. When the appropriate treatment is antibiotics, why the urgency to test an outmoded, inferior and potentially dangerous treatment on children, especially when the vaccine itself frequently causes severe adverse reactions?

Giving a Risky Vaccine to Children Violates Federal Regulations

The statistics for adverse reactions from anthrax vaccine are very concerning:

According to the 2002 anthrax vaccine label, between five and 35 percent of vaccine recipients develop systemic adverse reactions.

Of those, approximately six percent are serious and life threatening, including birth defects, hospitalization, permanent disability and death.

According to the Government Accountability Office (GAO), one to two percent of vaccinated individuals may experience severe adverse reactions harmful enough to result in death or disability.

There is no acceptable justification for exposing healthy children to these dangers. In fact, doing so is a violation of a US statute requiring children to be exposed to no greater than a "minor increase over minimal risk." The child subjects of the proposed vaccine trial are not receiving treatment for any condition or other problem affecting their health or welfare ("nontherapeutic research"), so do not stand to benefit in any way, which is against Federal regulations.

In fact, the Presidential Commission was never informed of a pivotal trial involving the safety issues with anthrax vaccine. The complete findings of this trial were submitted to the FDA in 2009 but have never been published or disclosed to the public. The trial found that 186 people suffered 229 serious adverse events during the trial, with seven deaths. That is, 12 percent of the subjects suffered serious adverse events! Department of Health and Human Services (DHHS) Secretary Sebelius has the authority to demand the release of this safety data at any time, but she has not done so.

If the proposed trial were going to provide meaningful answers to any questions about the vaccine's safety for children, thousands of children would have to be experimented upon. The proposed trial, which involves a much smaller number of children, would have no scientific or clinical value at all and would therefore be unethical and illegal under US statute.

Whose children will be the sacrificial lambs in a corporate-government collusion scheme to expand the BioThrax stockpile and create a potential civilian market for the vaccine's sole US manufacturer, Emergent BioSolutions? And what happens when something goes wrong? Who is liable?

Government Shields Vaccine Makers from All Liability

If you're in the military, you can't sue the government for damages for injuries that occurs during your military service (Fere's Doctrine). Instead, you have to use the VA health system. The situation is just as dire for civilians when it comes to pandemic vaccines, such as the now infamous H1N1 swine flu vaccine, as well as anthrax, thanks to the PREP Act passed by Congress and signed into law in 2006.

The PREP Act, or Public Readiness Emergency Preparedness Act, said that if a public health emergency is declared by the federal government, the manufacturer of a product made to address the emergency would be given a near blanket waiver of liability. This waiver of liability would apply to the vaccine manufacturer, the doctors administering the vaccine, the distributors, and anybody in the government who had been part of the planning for a vaccine or drug program. The waiver was supposed to be for "emergencies" only.

In spite of the lack of any credible anthrax threat, DHHS Secretary at that time, Michael Leavitt, invoked the extraordinary "emergency" powers given to him by Congress and declared anthrax a public health emergency in 2008, effective through 2015. So, when the government declares anthrax a "public health emergency," you are prevented from seeking damages if you (or your child) are injured by the anthrax vaccine. And your risk of being injured by this vaccine, based on its history, is quite likely.

Problem-Reaction-Solution... Will You Take the Bait?

There is a strategy that some refer to as "Problem-Reaction-Solution," which looks like this:

You create or manufacture a problem

There is a public reaction

You solve the problem in a way that completes your own agenda

The threat of bioweapons can easily be manipulated for financial gain using the Problem-Reaction-Solution process. With respect to the anthrax vaccine, the problem created after 9-11 was the fear of bioterrorism attacks on the U.S. civilian population. People reacted to the implied threat of further attacks with widespread panic, and the government and pharmaceutical industry came to the rescue with plans to expand production and civilian stockpiling of anthrax vaccine already being given to U.S. military personnel.

The bizarre anthrax letters incident 10 years ago boosted the biodefense budget by $60 billion dollars, and Emergent BioSolutions, the sole producer of BioThrax vaccine for the US military, received a $1.4 billion contract to produce anthrax vaccine for public use. This contract was recently renewed to the tune of $1.25 billion.

The PREP Act in combination with the Problem-Reaction-Solution process creates a massive opportunity for vaccine makers by allowing them to "sneak in" new ingredients and adjuvants (immune-boosting additives with potentially unknown or risky profiles) under the guise of needing to prepare for a bioterrorism "emergency." Then, since the new vaccine ingredient has been used already, they can use these ingredients in other vaccines without having to go through a rigorous approval process.

By declaring a public health emergency, Secretary Leavitt did not protect the public health but instead sacrificed the public's civil and human rights, while protecting biodefense stakeholders. The Presidential Commission's review process itself was extremely flawed, and there were multiple conflicts of interest. AHRP identified the following issues:

No expert witnesses knew anything about anthrax or anthrax vaccine and there was no scientific testimony about the vaccine's safety or efficacy in adults. They never even looked at the vaccine label!

No details about the proposed vaccine trial were provided, and the issue of anthrax risk was never discussed.

The trial on children is ostensibly to test the vaccine for post-exposure use in an emergency, but in fact the trial would involve pre-exposure, which might lay the groundwork for the vaccine's routine use in children

The Commission was never briefed on the existing legal cases relevant to pediatric research that provides them no benefit

The Real Motivation: Increasing Vaccine Profits by Any Means Possible

The entire history of the anthrax vaccine enterprise has been rife with evidence of profiteering at taxpayer expense. To gain insight about the motives behind DHHS' anthrax policies, you need to examine the hidden web of financial conflicts of interest and revolving doors. The government was able to capitalize on the public's post-9/11 fear of another terrorist attack by getting away with pretty much anything. The country was manipulated into believing it "needed" a 2-billion dollar stockpile of anthrax vaccine, which DHHS continues to maintain in spite of safety concerns about the vaccine and lack of efficacy data. Indeed, the anthrax vaccine has been exceedingly profitable to BioThrax manufacturer Emergent BioSolutions:

On October 3, 2011, the government awarded Emergent BioSolutions a five year contract worth up to $1.25 billion to provide millions of doses of anthrax vaccine for government stockpiles

Emergent BioSolutions has sold more than 55 million vaccine doses to the US government and plans to supply another 44.75 million doses over the next few years5

Emergent BioSolutions has made more than one billion dollars in profit6

Realizing that experimenting with children is fraught with difficulty in terms of informed consent and ethical restrictions, they cleverly devised a method for conducting the trial that would sidestep these problems by starting with 18 to 20 year olds, who CAN give informed consent, then working their way down through the age groups. This "method" has an underlying assumption: that data do not exist on this vaccine's safety, and must therefore be obtained for 18 to 20 year olds. Of course, that is hardly the case. According to AHRP, such a trial could begin to overturn existing federal protections for child subjects.

Once you consider the issue in its broader context, you can only conclude that the real goal of this child trial is expanding civilian vaccinations and marketing the vaccine to parents, rather than obtaining safety and efficacy data. Naturally, the financial incentives are enormous for increasing vaccine stockpiles and widening its use.

In Summary

The government's proposed anthrax vaccine trial for children is being vehemently opposed by AHRP, citing conflicts of interest, corrupt political motives and financial incentives, and a blatant disregard for federal regulations that protect children from unnecessary harm. The entire premise that we are at high risk for a bioterrorist attack is erroneous, and the idea that a vaccine is needed is ridiculous, as antibiotics have proven to be 100 percent effective for anthrax exposure. This is yet another example of greed and political corruption trumping public health.

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